Biokyra

Sunday, April 24, 2016

Major challenges
influence how the medtech industry works in term of product management, market
positioning, and early-stage design and development. From downward cost
pressures, reimbursement and regulatory requirements, increased competition,
and, internal pressure to generate sales. As easy as it sounds, a customer-centric
approach is a difficult thing to accomplish – but it helps medtech
companies to think differently, engage with customers differently, and
design and market devices differently. Here’re some tips on how adopt this
strategy:

* Start with the Right Mindset:
being a medical device company means that you are in the business of restoring
and improving health. “Recognizing that will help you stay focused on
making devices customers want and will buy.”

* Get Customer Input the Right Way:
don’t just ask what features customers want in your product – ask what outcomes
they want from using your product. “It is not the responsibility of
customers to figure out what features will provide the experience they desire
or achieve the result they want. What customers can meaningfully talk about is
what experience and outcomes they want.”

* Minimum Viability, Maximum Value:
“Put in just enough features so you validate that what you’re making is viable.
Viable means the lean product sufficiently meets a customer need and will
sell”. In the medical sector, this could be harder due to regulatory
approvals, reimbursement issues, and clinical trials. However, this is an
attempt to minimize both investment and risk to avoid going to market with an
expensive, feature-rich product that bombs. Maximum value is all about
how much value your product can provide to customers.

Despite significant barriers to successfully launch a
product, this is an industry that exists to save lives – so companies
should stay focused on the value, not product features.

Sunday, April 10, 2016

BIOMEDevice
Boston conference will happen between April 13-14 and one of the speakers is
Bill Betten, director of business solutions at Devicix (Eden Prairie, MN). He
recently gave an interview forQmed about the
reasons why medical innovation is so hard to fullfil. “You build around what
has been done before. When people hear that statement, they sometimes say
things like: ‘what about the implantable pacemaker? Surely that was not
incremental?’ But you could argue that the pacemaker certainly built on what
came before,” says Betten.

Here
are some reasons why leapfrog innovation rarely happens in the medical
industry, according to him:

- Financial Constraints: makes it
difficult for companies to create breakthrough products or create devices that
are less expensive but functionally equivalent to older technology. Due to
increasingly cost-conscious hospitals, companies are being forced to reduce
costs of their products. “In the past, it was commonplace for device makers to
charge substantially more money for new products that only had minor
improvements over the previous-generation product. That isn’t the case anymore:
many hospitals are now hesitant to invest in new devices that are not
demonstrably better than established technologies.”

Another important point is the vital role
of medical device start-ups in developing revolutionary medical technology: one
has to add the struggle they go through to obtain venture capital funding for
their projects.

- Regulatory Challenges: in a highly
regulated industry like the medical sector, product development costs can
skyrocket. “Regulatory costs run in the tens of millions of dollars for most
510(k) products, according to a report onAdvaMed’swebsite. For PMA products, marketing a medical device in the
United States can take close to $100 million on average.”

These obstacles are
faced by medical start-ups all over the world andBiokyra is no exception. The Brazilian-based company is currently
developing medical devices in the vascular area, going through regulatory
processes and filing Brazilian and international patents.